The Alliance

The Weekly Dose | 12.20.19

December 20, 2019 1:29 pm

If you read the “What We’re Reading” section below, you will find several stories that show innovation is alive and well in America and, when it comes to developing innovative new medical treatments, the private sector is the driving force behind the race to find new cures. In a letter to The Wall Street Journal, leukemia survivor Erica Nurnberg discussed what this innovation meant to her.

 

Nurnberg explained that her “life was saved in no small part due to the brilliant research at Pfizer Inc.” Patients with her form of leukemia often “succumb to the disease in the first 10 days after diagnosis due to hemorrhaging.” Nurnberg was given Mylotarg, which was approved by the U.S. Food and Drug Administration “only months before” her diagnosis, and which Nurnberg credits with preventing hemorrhaging. Nurnberg wants the the U.S. Senate and the White House to reject H.R. 3 because it will negatively impact innovation.

 

A former U.S. senator does, too. In Morning Consult, Arkansas Democrat Blanche Lincoln writes, “If we want our children and grandchildren’s health care to be better than our own, then we must stay true to our commitments and never sacrifice access to the high-quality medical care that Americans deserve” by rejecting H.R. 3.

 

We’ll be taking a break during the holidays, but we’ll be back in touch in 2020. In the meantime, if you need more info for a story or have questions, please email us. We look forward to working with you.

 

Best,

Patrick O’Connor – Executive Director

Rosemarie Calabro Tully – Communications Director

 

 

APMI IN THE NEWS

 

APMI released a statement on the Trump administration’s drug importation plan. Executive Director Patrick O’Connor said: “This proposal to allow drug importation exposes American patients to unnecessary risk without lowering out-of-pocket costs in a meaningful way. HHS Secretary Alex Azar previously derided this as a ‘gimmick’ and every FDA and HHS director since 2000 has raised concerns about the safety of similar proposals. Drug importation is not our silver bullet, but rather an ineffective political ploy that fails to lower prices, endangers consumer safety, and threatens continued medical innovation.”

 

TWEETS OF THE WEEK

 

- A new @JohnsHopkins report studied top US drugmakers to conclude #pricecontrols won’t hurt #innovation. Considering that ~90% of biopharma never sees a profit, “that’s like assuming all musicians are millionaires from [just] looking at the Grammy winners.” https://bit.ly/2sHpiuY Click here to RT.  

 

- In 2010, 64% of foreign manufacturing plants had never been inspected by @FDA_Drug_Info. American #patients are right to question the safety of #drug #importation. Click here to RT.

 

- .@HHSGov reports that #drugprices fell by 1% last year. Now that innovators are making strides to lower drug costs, it's time for Congress to take on the hospitals, insurers and #PBMs that made up the remaining 91% of #healthcare spending in 2018. https://abcn.ws/36TwMtk Click here to RT.

 

THE STORIES THAT DIDN’T GET ENOUGH ATTENTION

 

Check out and share on Twitter our latest blog posts:

 

- Drug Importation: Unsafe, Unworkable, And Ineffective. The U.S. Department of Health and Human Services has released President Donald Trump’s plan to allow importation of prescription drugs from foreign countries. While the administration made a huge press push in support of the plan, coverage also highlighted significant concerns about the proposal. We examine that anxiety in a new blog post. Click here to read the full blog post.

 

- Drug Importation: “Not Your Silver Bullet.” With an election of their own on the horizon, Canadian officials have begun to push back. According to Reuters, talking points developed by the country’s foreign ministry outline Canada’s “clear” opposition to the idea. The foreign ministry believes importation measures could exacerbate the already short supply of drugs in Canada, and could drive up prices there. We offer a few other reasons drug importation is a bad idea. Click here to read the full blog post. Share on Twitter here.

 

- Drug-Pricing Proposals Should Worry Patients Looking for a Cure. Whether it’s through stripping important patents, imposing foreign reference pricing, or placing arbitrary limits on drug prices, certain policy proposals threaten to smother innovation and reduce access to lifesaving care, leaving #patients worse off. Click here to read the full blog post. Share on Twitter here.

 

WHAT WE’RE READING

 

- Does The Federal Government Finance Drug Innovation. No, says Sandeep Shah. Writing in The Detroit News, he explains the National Institutes of Health “simply doesn't have access to that kind of capital. In 2017, drug companies spent $97 billion on R&D in the United States — close to triple the entire NIH budget.” Meanwhile, a new Research!America report found total spending on health and medical research in 2018 totaled $194 billion. The private sector was responsible for more than two-thirds of that spending and government was responsible for 22 percent. Private sector research spending increased 40 percent between 2013 and 2018. The American Council on Science and Health has more information on this topic in this blog post.

 

- Can Biotech Eliminate The Side Effects Of Chemo? The industry is working on it. STAT News Adam Feuerstein explores how the researchers are looking for ways to mitigate or eliminate the toxicity of busulfan, a chemotherapy first developed in the 1950s.

 

- Can A Drug For Leukemia Help Treat Parkinson’s Disease? NPR reports, “In a study of 75 people with Parkinson’s,” the Georgetown University Medical Center found nilotinib, a treatment for leukemia, “appeared to improve quality of life and boost the chemical dopamine.” Dr. Fernando Pagan, director of the medical center’s movement disorders program, said, “We are seeing signals that this may be a potential treatment for our Parkinson’s disease patients.” MedPage Today has more.

 

- Hope For Patients With Major Depressive Disorder. Reuters reports, “Axsome Therapeutics Inc. said on Monday its drug succeeded in reducing symptoms of major depressive disorder in a late-stage trial. …” The wire service also noted: “There are few treatments available to people suffering from depression and some of these carry significant side effects. A large number of patients do not respond to the existing treatments.”

 

- Hope For Patients With A Rare Genetic Liver Disease. STAT News reports that lumasiran, an RNAi therapy under development by Alnylam and that could treat primary hyperoxaluria type 1, or PH1, a rare, genetic liver disease met the goals of a recent clinical trial. STAT explained that in the study, the drug reduced the amount of oxalate in patients’ urine, a result the company believes will translate to relief from PH1’s painful symptoms.

 

- Looking For Treatments For The Millions Of Americans Who Suffer From Migraines. The Hartford Courant features Biohaven Pharmaceuticals, a New Haven-based start-up, that is working to find treatments to help the one in 10 Americans who suffer from migraines.

 

- Drug Importation Won’t Work. That’s according to this account in POLITICO. The Beltway newspaper reports: “Wall Street analysts are predicting the rule will have little to no financial impact on the drug industry. In public, industry officials gnash their teeth over the rule. In private, they see little impact. When the nonpartisan Congressional Budget Office reviewed the prospects of importation in 2004, it concluded that it would lead to few drugs entering the U.S., and small savings. And only drops from that pot of savings will flow to consumers. … ‘I think this will end up just as a dud,’ said a former FDA official. ‘It’s not an existential threat to the safety of the U.S. drug supply, nor is it a solution to the drug pricing issue. It’s a sideshow.’” Axios also weighed in on this issue.

 

QUOTATION OF THE WEEK

 

Writing in The Washington Examiner, Rosa Mendoza, president and CEO of ALLvanza, a nonprofit organization devoted to “advancement of the Latinx and other underserved communities,” said:

 

“A Maryland-based biotech firm may have just cured HIV. That company recently submitted an FDA application for AGT103-T, an HIV therapy that could eliminate the virus in a single dose. If the agency approves the drug, clinical trials could begin as soon as January. The news is a good reminder of how drug innovation can address the biggest public health crises of our time. Although medical progress benefits all patients, such breakthroughs are especially valuable to underserved communities. To keep this progress going, lawmakers can consider policies that encourage investments in breakthrough biomedical research and science education.”